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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Telmisartan and Amlodipine Tablets Recalled for Impurity Specification Failure

Agency Publication Date: April 11, 2019
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Summary

Approximately 12,504 bottles of Telmisartan and Amlodipine (80 mg/5 mg) tablets are being recalled. This medication, used to treat high blood pressure, failed quality testing during an 18-month stability study because it did not meet specifications for impurities and degradation. Consumers should contact their healthcare provider or pharmacist to discuss alternative treatments and return any unused medication to the pharmacy for a refund.

Risk

The tablets may contain higher levels of impurities or degradation products than allowed, which can potentially reduce the medication's effectiveness or expose patients to unintended chemical compounds over time.

What You Should Do

  1. Check your prescription bottles to see if you have Telmisartan and Amlodipine Tablets 80 mg/5 mg (30-count bottles) with NDC 68180-198-06.
  2. Verify if your bottle matches one of the following lot numbers and expiration dates: Lot G705843 (Exp. April 2019), Lot G707763 (Exp. August 2019), or Lot G800434 (Exp. November 2019).
  3. Contact your healthcare provider or pharmacist immediately for guidance and to obtain a replacement prescription before you stop taking the medication.
  4. Return any unused tablets from the affected lots to your pharmacy for a refund and contact Lupin Pharmaceuticals Inc. for further instructions.
  5. For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund for unused prescription medication.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Telmisartan and Amlodipine Tablets 80 mg/5 mg (30 tablet bottle)
Model:
NDC 68180-198-06
Recall #: D-1121-2019
Lot Numbers:
G705843 (Exp. date April, 2019)
G707763 (Exp. date August, 2019)
G800434 (Exp. date November, 2019)
Date Ranges: April 2019, August 2019, November 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82528
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: wholesalers; drug chains; mail order pharmacies
Manufactured In: India, United States
Units Affected: 12,504 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.